To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Advisory Panel Recommends Zoloft For Posttraumatic Stress Disorder URL: http://www.pslgroup.com/dg/13988E.htm Doctor's Guide October 14, 1999
NEW YORK, NY -- October 14, 1999 -- An advisory panel of the U.S. Food and Drug Administration recommended its anti-depressant Zoloft (sertraline hydrochloride, Pfizer Inc.) for an indication of posttraumatic stress disorder (PTSD).
Zoloft is the first medicine to receive a FDA advisory panel approval recommendation for the treatment of PTSD. Zoloft is currently indicated for major depression, panic disorder, and obsessive-compulsive disorder.
Patients suffering from PTSD experience significant distress or impairment in normal functioning. A traumatic event involves reaction to serious injury or other physical threat. Symptoms can include re-experiencing the traumatic event, commonly known as flashbacks, overall emotional numbness, or increased anxiety.
Approximately 50 percent of the general population are exposed to a traumatic event during their lifetime. Ten to twenty percent of those develop PTSD. The prevalence of PTSD is twice as high in women as in men.
More than 100 million prescriptions for Zoloft have been written in the United States since its approval in 1992. Pfizer said it will continue providing information about its PTSD clinical trials program to the FDA during the agency's review process.
Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) and a MAOI is contraindicated for at least 14 days after discontinuation of Zoloft. The most common side effects in adults with depression, panic disorder, obsessive-compulsive disorder, and other premarketing controlled trials include nausea, insomnia, diarrhea, ejaculation failure (primarily ejaculatory delay) and somnolence.
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